Patient interface device including a coating adhesive layer

ABSTRACT

Various embodiments of a patient interface device, such as a mask, nasal pillow, or nasal cannula, that includes an adhesive layer provided on a surface thereof that is structured to temporarily bond to the skin of a user of the patient interface device. The adhesive layer may include a bonding agent, such as a polymer gel, having a residual extraction force of between about 50 grams and about 200 grams.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional under 35 U.S.C. §120 of U.S. patentapplication Ser. No. 12/743,045, filed May 14, 2010, which claimspriority under 35 U.S.C. §119(e) from provisional U.S. patentapplication No. 60/988,914, filed Nov. 19, 2007, the contents of whichare incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to patient interface devices, and inparticular to a patient interface device, such as a mask or cannula,that includes one or more coating layers acting as an adhesive and, incertain applications, a sealant.

2. Description of the Related Art

A variety of respiratory masks are known which have a flexible seal thatcovers the areas surrounding the nose and/or mouth of a human user andthat are designed to create a continuous seal against the user's face.Because of the sealing effect created, gases can be provided at apositive pressure within the mask for consumption by the user. The usesfor such masks include high altitude breathing (aviation applications),swimming, mining, fire fighting and various medical diagnostic andtherapeutic applications.

One requisite of many of these masks, particularly medical respiratorymasks, is that they provide an effective seal against the user's face toprevent leakage of the gas being supplied. Commonly, in conventionalmask configurations, a good mask-to-face seal has been attained in manyinstances only with considerable discomfort for the user. This problemis most crucial in those applications, especially medical applications,which require the user to wear the mask continuously for hours orperhaps even days. In such situations, the user often will not toleratethe mask for long durations and therefore optimum therapeutic ordiagnostic objectives will not be achieved, or will be achieved withgreat difficulty and considerable user discomfort.

Several types of respiratory masks for the types of applicationsmentioned above are known. Perhaps the most common type of maskincorporates a smooth sealing surface extending around the periphery ofthe mask and exhibiting a generally uniform, i.e., predetermined orfixed, seal surface contour that is intended to be effective to sealagainst the user's face when force is applied to the mask with thesealing surface in confronting engagement with the user's face. Thesealing surface typically consists of an air or fluid filled cushion, orit may simply be a molded or formed surface of a resilient seal elementmade of an elastomer such as plastic, rubber, silicone, vinyl or foam.

Such masks have performed well when the fit is good between the contoursof the seal surface and the corresponding contours of the user's face.This may occur, for example, if the contours of the user's face happento match well with the predetermined contours of the seal. However, ifthe seal fit is not good, there will be gaps in the seal-to-faceinterface resulting in gas leaking from the mask at the gaps.Considerable force will be required to compress the seal member to closethe gaps and attain a satisfactory seal in those areas where the gapsoccur. Such force is undesirable because it produces high pressurepoints elsewhere on the face of the user where the mask seal contour isforcibly deformed against the face to conform to the user's facialcontours. This will produce considerable user discomfort and possibleskin irritation and breakdown anywhere the applied force exceeds thelocal perfusion pressure, which is the pressure that is sufficient tocut off surface blood flow. Ideally, contact forces should be limitedbetween the mask and the user's face to avoid exceeding the localperfusion pressure, even at points where the mask seal must deformconsiderably.

The problem of seal contact force exceeding desirable limits is evenmore pronounced when the positive pressure of the gas being supplied isrelatively high or is cyclical to relatively high levels. Because themask seals by virtue of confronting contact between the mask seal andthe user's face, the mask must be held against the face with a forcesufficient to seal against leakage of the peak pressure of the suppliedgas. Thus, for conventional masks, when the supply pressure is high,head straps or other mask restraints must be relatively tightlyfastened. This produces high localized pressure on the face, not only inthe zone of the mask seal, but at various locations along the extent ofthe retention straps as well. This, too, will result in discomfort forthe user after only a brief time. Even in the absence of excessivelocalized pressure points, the tight mask and head straps may becomeuncomfortable, and user discomfort may well cause discontinuedcooperation with the treatment regimen. Examples of respiratory maskspossessing continuous cushion sealing characteristics of the type justdescribed are provided in U.S. Pat. Nos. 2,254,854 and 2,931,356.

In addition, nasal cannulas are used in a variety of clinical situationssuch as oxygen delivery, gas sampling (e.g., carbon dioxide), andpressure measurement. Nasal cannulas and similar devices are generallyretained in place by the tension resulting from looping the associatedtubing or cable over the patient's ears, which often creates discomfort.Patient movement resulting from the discomfort may cause the nasalcannula to become dislodged.

There is thus room for improvement in the area of mask, cannulas, andsimilar patient interface devices.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, the invention provides a patient interface device,such as a mask or nasal pillow, that includes at least one seal elementand an adhesive layer provided on an outer surface of the at least oneseal element. The adhesive layer is structured to temporarily bond tothe skin of the user of the patient interface device and comprises abonding agent having a residual extraction force of between about 50grams and about 160 grams. The bonding agent may be a cross linkedpolymer gel, such as a silicone gel or a polyurethane gel. In oneparticular embodiment, the adhesive layer further includes a coatinglayer formed by co-curing the bonding agent with at least one layer of aprimer material. The adhesive layer may comprise at least one generallyannular strip, of uniform or varying width, and in particular may be aplurality of concentric generally annular strips. Furthermore, theadhesive layer may have a generally uniform height, or, alternatively,may have a varying height. In one particular embodiment, the adhesivelayer comprises a plurality of deposits of the bonding agent provided onthe outer surface of the at least one seal element. Such deposits mayhave similar or differing sizes, and may have similar or differinggeometric shapes (such as circular, triangular or oblong shapes).

Another embodiment provides a patient interface device that includes amask having a body, at least one seal element coupled to the body, afacial support having an engagement surface coupled to the body, and anadhesive layer provided on the engagement surface, the adhesive layercomprising a bonding agent having a residual extraction force of betweenabout 50 grams and about 160 grams. This patient interface device may ormay not also include an adhesive layer on a sealing element of the mask.

In another embodiment, a nasal cannula is provided that includes one ormore nasal inserts for delivering a fluid to the nasal passageway of auser, at least one attachment panel, and an adhesive layer provided onthe at least one attachment panel and being structured to temporarilybond to the skin of the user, the adhesive layer comprising a polymergel such as a silicone gel or a polyurethane gel. The adhesive layer mayfurther include a coating layer formed by co-curing the polymer gel withat least one layer of a primer material. In the preferred embodiment,the polymer gel has a residual extraction force of between about 50grams and about 160 grams. In another particular embodiment, the nasalcannula includes a fluid delivery tube in fluid communication with theone or more nasal inserts. In this embodiment, the fluid delivery tubeis inserted through one or more apertures provided in the at least oneattachment panel, whereby the at least one attachment panel is free tomove relative to the fluid delivery tube prior to being temporarilybonded to the skin of the user. In still another particular embodiment,the nasal cannula includes a first fluid delivery tube and a secondfluid delivery tube in fluid communication with the one or more nasalinserts, wherein the at least one attachment panel comprises a firstattachment panel and a second attachment panel connected to one anotherby a connecting strip, In this embodiment, the first fluid delivery tubeis inserted through an aperture provided in the first attachment paneland the second fluid delivery tube is inserted through an apertureprovided in the second attachment panel, whereby the first attachmentpanel is free to move relative to the first fluid delivery tube and thesecond attachment panel is free to move relative to the second fluiddelivery tube.

In yet another embodiment, the invention provides a nasal cannula thatincludes one or more nasal inserts for delivering a fluid to the nasalpassageway of a user, a fluid delivery barrel in fluid communicationwith the one or more nasal inserts, and an adhesive layer provided onone or more outer surfaces of the fluid delivery barrel and beingstructured to temporarily bond to the skin of the user, the adhesivelayer comprising a polymer gel such as a silicone gel or a polyurethanegel. The adhesive layer may further include a coating layer formed byco-curing the polymer gel with at least one layer of a primer material.In the preferred embodiment, the polymer gel has a residual extractionforce of between about 50 grams and about 160 grams.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate presently preferred embodiments ofthe invention, and together with the general description given above andthe detailed description given below, serve to explain the principles ofthe invention. As shown throughout the drawings, like reference numeralsdesignate like or corresponding parts.

FIG. 1 is a front elevational view and FIG. 2 is a cross sectional viewof a respiratory mask according to an embodiment of the invention;

FIGS. 3 and 4 are front elevational views of a respiratory maskaccording to alternate embodiments of the invention;

FIGS. 5A, 5B and 5C are schematic diagrams showing the adhesive layer ofthe present invention in the form of a pattern of deposits of a bondingagent on a sealing element;

FIGS. 6A through 6E are schematic diagrams of various embodiments of anadhesive layer of the present invention;

FIGS. 7 and 8 are top plan and cross sectional views, respectively, of apatient interface device in the form of a nasal pillow according toanother embodiment of the invention;

FIG. 9 is a front elevational view of a mask according to yet anotherembodiment of the invention;

FIGS. 10 and 11 are top plan views of forehead supports forming a partof a mask according to alternative embodiments;

FIG. 12 is an isometric view of a patient interface device in the formof a nasal cannula according to further embodiment of the invention;

FIG. 13 is a schematic diagram showing the patient interface device ofFIG. 12 in use;

FIG. 14A is an isometric view of a patient interface device in the formof a nasal cannula according to an alternate further embodiment of theinvention;

FIG. 14B is an isometric view of a nasal cannula according to analternative embodiment which is a variation of the nasal cannula shownin FIG. 14A wherein only a single fluid delivery tube is employed;

FIG. 15 is a schematic diagram showing the nasal cannula of FIG. 14B inuse;

FIGS. 16A and 16B are isometric views of a nasal cannula according to afurther alternate embodiment of the present invention;

FIG. 17 is a schematic diagram showing the nasal cannula of FIGS. 16Aand 16B in use;

FIG. 18 is an isometric view of a patient interface device in the formof a nasal cannula according to still a further embodiment of theinvention;

FIG. 19 is an isometric view of a patient interface device in the formof a nasal cannula according to yet a further embodiment of theinvention; and

FIG. 20 is a schematic diagram showing of a patient interface device inthe form of a nasal cannula according to yet a further embodiment of theinvention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Directional phrases used herein, such as, for example and withoutlimitation, top, bottom, left, right, upper, lower, front, back, andderivatives thereof, relate to the orientation of the elements shown inthe drawings and are not limiting upon the claims unless expresslyrecited therein.

As employed herein, the term “patient interface device” refers to anysuitable mechanism for transporting gas to and/or from the airway of apatient and expressly includes, but is not limited to, non-invasivepatient interfaces such as masks (e.g., without limitation, masksincluding support elements such as forehead supports and cheek pads andfull face masks such as the Total™ face mask sold by the assigneehereof), nasal cannulas, nasal masks (including tip of the nose maskssuch as the Simplicity™ and Comfort Lite™ masks sold by the assigneehereof), combination nasal/oral masks and nasal pillows.

As employed herein, the statement that two or more parts or componentsare “coupled” together shall mean that the parts are joined or operatetogether either directly or through one or more intermediate parts orcomponents.

As employed herein, the term “number” shall mean one or more than oneand the singular form of “a”, “an”, and “the” include plural referentsunless the context clearly indicates otherwise.

FIG. 1 is a front elevational view and FIG. 2 is a cross sectional viewof a respiratory mask 10 according to an embodiment of the invention.The respiratory mask 10 includes a shell or body 12 having an open side14 that defines a generally annular surface 16 to which is sealinglyaffixed a seal element 18. The mask body 12 is preferably, although notnecessarily, a generally rigid shell, whereas the seal element 18 is aflexible, resilient unitary member made of, for example, an elastomersuch as plastic, rubber, silicone, vinyl or foam.

The mask body 12 also defines an opening 20 to which there is attached afluid coupling device, such as a swivel conduit 21 (FIG. 2), forcarrying fluid, such as a breathing gas, between the chamber within themask 10 and an external gas source (not shown), such as a blower orother suitable device. It is to be understood that the present inventioncontemplates a variety of different fluid coupling devices that could beattached, either permanently or selectively, to the opening 20 to carryfluid to or from the chamber defined by the mask 10.

The mask 10 shown in FIGS. 1 and 2 is a nasal mask that accommodates thenasal regions of the user's face. It is to be understood, however, thatthe present invention also contemplates other patient interface devicessuch as, without limitation, a full face or an oral/nasal mask thataccommodates both the mouth and nose of a user or a total face mask thataccommodates substantially the entire facial area of the patient. As isconventional, the mask body 12 also preferably includes fasteningdevices, such as tabs 25 or the like, that connect to suitableadjustable retention straps (not shown) for retaining the mask withrespect to the user's face. Although two such devices are illustrated inFIGS. 1 and 2 and are generally arrayed at selected corners of the mask10, it is to be understood that other configurations, arrangements,numbers (including none) and locations of fastening devices can beprovided without deviating from the principles of the present invention.Although not illustrated, the present invention contemplates providingone or more exhaust ports or other venting mechanisms at a location orlocations, such as in the seal element 18, the mask body 12, the conduit21 or at a junction between these components, to exhaust gas expired bythe user to atmosphere.

The seal element 18 includes a solid, yet highly resilient andself-sustaining compressible, generally annular member 27 comprising aperipheral wall portion 28 having a generally annular base or inner end30 configured so as to substantially match the surface 16 of the maskbody 12 to which it is attached. The peripheral wall portion 28 furtherestablishes an outer end 32 generally opposite inner end 30. The outerend 32 defines a generally annular contoured surface 34. The contour ofsurface 34 is preformed to closely approximate the surface contour of auser's facial structure, especially in the areas of the bridge of thenose, the cheeks adjacent the nose, the space intermediate the nose andupper lip, and the intervening areas contiguous to these. It is to beunderstood that the contour of the surface 34 can have alternativeconfigurations depending on the type of mask to which the seal element18 is attached. For a full face mask, for example (not illustrated), thesurface 34 may be contoured to accommodate the user's chin in lieu ofthe area intermediate the nose and upper lip. In either case, variationin the user's facial structure, especially in the area of the bridge ofthe nose, for example, makes considerable flexibility of the sealelement 18 desirable to accommodate the many different facial contourslikely to be encountered.

According to an aspect of the present invention, an adhesive layer 40made of a bonding agent is provided on and bonded to the contouredsurface 34 of the annular member 27 of the seal element 18. The adhesivelayer 40 has a level of stickiness that will cause it to temporarilybond to the skin of the user of the mask 10, preferably without leavinga significant amount of residue when removed. The adhesive layer 40 willthus provide a bonding seal between the mask 10 and the user's skin soas to reduce and/or eliminate leaks. In addition, with the sealing bondprovided by the adhesive layer 40, the strapping forces (through thetabs 25 or the like) can be reduced. For example, a mask may need asmaller number of straps than would be needed without the adhesive layer40. In fact, in some applications (e.g., flow pressures of 8 cm H2O orless), the adhesive layer 40 may eliminate the need for strappingaltogether.

In the preferred embodiment, the bonding agent of the adhesive layer 40will have a residual extraction force of between about 50 grams andabout 200 grams, and most preferably between about 50 grams and about160 grams. As used herein, the term residual extraction force means theforce required to pull a probe about 12.7 mm (about 0.5 inches) roundfrom the subject material when the probe has been inserted to a depth ofabout 10 mm (about 0.3937 inches) in a container about 60 mm (about2.362 inches) in diameter and about 45 mm (about 1.772 inches) deep thatis filled with the subject material. In one particular embodiment, thebonding agent of the adhesive layer 40 is a cross linked polymer gel(most preferably with no plasticizer) such as, without limitation, asilicone gel or a polyurethane gel. As is known, a general purposesilicone gel typically has a residual extraction force of 8 to 15 grams.In one preferred embodiment, the bonding agent of the adhesive layer 40is a silicone gel having a residual extraction force of about 160 grams,which is ten fold stickier than the general purpose silicone gel.

Due to the soft nature of the adhesive layer 40, it is possible that insome applications, a small amount of the adhesive layer 40 may separatetherefrom under physical rubbing and be left on the user's skin as aresidual material. In order to avoid this phenomenon, the adhesive layer40 in one particular embodiment may further include a coating layerformed by co-curing the bonding agent with layer of a primer materialthat will resist material separation. For example, and withoutlimitation, in the case where the bonding agent of the adhesive layer 40is a silicone gel, any non-gel based silicone, such as a soft RTV-2material or an LSR (liquid silicone rubber) material can be used as theprimer, and the case where the bonding agent of the adhesive layer 40 isa polyurethane gel, a solvent such as acetone can be used as the primer.

In the embodiment shown in FIGS. 1 and 2, the adhesive layer 40 is asingle, generally annular strip having a generally uniform widthprovided on the contoured surface 34 of the annular member 27 of theseal element 18. It is to be understood that this is meant to beexemplary only, and that many other configurations are possible for theadhesive layer 40. For example, as shown in FIG. 3, the adhesive layer40 may comprise two or more generally annular portions or strips (ofgenerally uniform or varying widths), or as shown in FIG. 4, theadhesive layer 40 may comprise a non-annular layer (of a generallyuniform or varying width), covering only a portion of the contouredsurface 34 of the annular member 27 of the seal element 18. In oneparticular embodiment, a generally annular relatively thin strip formingthe adhesive layer 40 may be provided at the outer edge of the contouredsurface 34 in order to provide effective sealing enhancement withoutmaking the entire contoured surface 34 sticky. Many other configurationsare also possible. For example, and without limitation, as seen in FIGS.5A, 5B and 5C, the adhesive layer 40 may be in the form of a series ormatrix or pattern (uniform or varying) of differently sized (FIG. 5A) orsimilarly sized (FIGS. 5B and 5C) generally circular, oblong and/ortriangular deposits of the bonding agent. Other geometric shapes arealso possible.

Furthermore, the height of the adhesive layer 40 (or portions thereof)can have various attributes for achieving different results. Forexample, as shown in FIG. 6A, the height of the adhesive layer 40 can begenerally uniform, resulting in a generally smooth surface thatmaximizes adhesion. A typical height may be on the order of about 0.010inches (about 0.254 millimeters) to about 0.125 inches (about 3.175millimeters), although other heights are possible and will depend on theparticular application. Alternatively, as shown in FIG. 6B, the heightof the adhesive layer 40 can be varied over the area of the adhesivelayer 40, resulting in a surface that provides enhanced surface ventingand makes the adhesive layer 40 easier to peel from the skin of theuser. These latter attributes will also be provided by the configurationof the adhesive layer 40 shown in FIG. 6C, which comprises a pattern ofgenerally circular deposits (i.e., mounds) of the bonding agent. Inaddition, the contoured surface 34 is often designed to have uneven wallthickness to promote softness and different flexibilities. Therefore,depending on the desired results, the height of the adhesive layer 40can vary with the thickness of the contoured surface 34. For example, asshown in FIG. 6D, the height of the adhesive layer 40 may increase whilethe thickness of the contoured surface 34 decreases. This will enhancethe bonding even at thinner sections of the contoured surface 34 withoutchanging the overall feel (softness) of the mask 10. Furthermore, asshown in FIG. 6E, the height of the adhesive layer 40 may increase whilethe thickness of the contoured surface 34 also increases. This willmaintain a more flexible structure.

FIGS. 7 and 8 are top plan and cross sectional views, respectively, of apatient interface device in the form of a nasal pillow 42 according toanother embodiment of the invention. The nasal pillow 42 includes firstand second naris members 44A and 44B having top surfaces in the form ofseal elements structured to engage the exterior surfaces of the nares ofthe nose of a user to deliver a fluid, such as air or oxygen, to thenasal passageway of the user. As seen in FIGS. 7 and 8, the top surfaceof each naris member 44A, 44B is provided with an adhesive layer 40 asdescribed elsewhere herein. The adhesive layer 40 of each naris member44A, 44B will thus provide a bonding seal between the nasal pillow 42and the user's skin at the exterior surfaces of the nares.

FIG. 9 is a front elevational view of a mask 46 according to yet anotherembodiment of the invention. The mask 46 is similar to the mask 10, andtherefore, as seen in FIG. 9, includes a number of the same parts. Themask 46 further includes a forehead support 48 connected to andextending from the mask body 12 through a support arm 49. The foreheadsupport 48 includes an engagement surface 50 structured to engage theforehead of the user. In prior masks, such an engagement surface 50would have two top straps extending therefrom in order to help to holdthe mask in place. In the embodiment of the mask 46 shown in FIG. 9, nosuch straps are provided. Instead, an adhesive layer 40 is provided onthe engagement surface 50 in order to provide a bonding seal between theforehead support 48 and the user's skin. FIGS. 10 and 11 are top planviews of forehead supports 48A and 48B according to alternativeembodiments. The forehead support 48A includes a hollow silicone rubberstructure 52 having an engagement surface 50 on which an adhesive layer40 is provided. The forehead support 48B includes a pair of hollowsilicone rubber structures 52A and 52B each having an engagement surface50 on which an adhesive layer 40 is provided. Although forehead supports48, 48A and 48B are shown for illustrative purposes as one particulartype of facial support, it should be understood that other types offacial supports, such as, without limitation, cheek pads, are alsopossible.

FIG. 12 is an isometric view of a patient interface device in the formof a nasal cannula 54 according to further embodiment of the invention.The nasal cannula 54 includes fluid delivery tubes 56A and 56B connectedto opposite ends of a fluid delivery barrel 58. The fluid delivery tubes56A and 56B are in fluid communication with a source of fluid (notshown), such as an oxygen source, and deliver the fluid, e.g., oxygen,from the source to the fluid delivery barrel 58. First and second nasalinserts 60A and 60B are in fluid communication with the fluid deliverybarrel 58. The first and second nasal inserts 60A and 60B are structuredto be received in the nares of a user so that the fluid, e.g., oxygen,can be delivered from the fluid delivery barrel 58 to the nasalpassageway of the user. The nasal cannula 54 further includes anattachment mechanism 62 for removeably attaching the nasal cannula 54 tothe user's face to assist in holding the nasal cannula 54 in place whilein use. In particular, the attachment mechanism 62 includes a firstattachment panel 64A and a second attachment panel 64B connected to oneanother by a connecting strip 66. As seen in FIG. 12, each attachmentpanel 64A, 64B includes an aperture 68A, 68B which receives therethrougha respective one of the fluid delivery tubes 56A and 56B in order tomoveably couple the attachment mechanism 62 to the remainder of thenasal cannula 54. Each attachment panel 64A, 64B includes an innersurface 70 which has provided thereon an adhesive layer 40 in any of theforms described elsewhere herein.

Referring to FIG. 13, when in use, the first and second nasal inserts60A and 60B are inserted within the nares 72A and 72B of the user. Inthat position, the attachment panels 64A and 64B are able to beremoveably adhered to the alar sidewalls 74A and 74B of the nose 75 ofthe user. Specifically, the adhesive layers 40 provided on the innersurfaces 70 of the attachment panels 64A and 64B are able to beremoveably adhered to the alar sidewalls 74A and 74B. As a result, thenasal cannula 54 is securely held in place while in use. As will beappreciated, each of the components of the nasal cannula 54 may bemolded out of a polymeric material such as, without limitation, siliconerubber or urethane.

FIG. 14A is an isometric view of a patient interface device in the formof a nasal cannula 76 according to an alternate further embodiment ofthe invention. The nasal cannula 76 is similar to the nasal cannula 54and, as seen in FIG. 14A, therefore includes a number of the samecomponents. In nasal cannula 76, however, the attachment panels 64A and64B are directly affixed on opposite sides of the fluid delivery barrel58 to respective fluid delivery tubes 56A and 56B. FIG. 14B is anisometric view of a nasal cannula 76′ according to an alternativeembodiment which is a variation of the nasal cannula 76 shown in FIG.14A wherein only a single fluid delivery tube 56 is employed. FIG. 15 isa schematic diagram showing the nasal cannula 76′ in use wherein theadhesive layers 40 provided on the inner surfaces 70 of the attachmentpanels 64A and 64B are removeably adhered to the alar sidewalls 74A and74B of the nose 75 of the user.

The nasal cannulas 54, 76 and 76′ shown in FIG. 12-15 are considereddouble cannulas because each of them includes two nasals inserts 60A and60B. FIGS. 16A and 16B are isometric views of a nasal cannula 78according to a further alternate embodiment of the present invention.The nasal cannula 78 is a single cannula and as such is structured to bereceived within a single nare of the user. FIGS. 16A and 16B show anasal cannula 78 adapted for insertion into the user's left nare as theshape of the attachment panel 64 generally matches contour of the leftalar sidewall 74B of the nose 75 of the user as seen in FIG. 17. As willbe appreciated, a nasal cannula 78 adapted for insertion into the user'sright nare is also possible. The nasal cannula 78 includes a singlefluid delivery tube 56 in fluid communication with a nasal insert 60.The nasal cannula 78 further includes an attachment mechanism 80 havingan attachment panel 64 which includes an aperture 68 which receivestherethrough the fluid delivery tube 56. As seen in FIGS. 16A and 16B,the end of the attachment mechanism 80 that is opposite the attachmentpanel 64 is affixed to the bottom of the nasal insert 60. The attachmentpanel 64 includes an inner surface 70 which has provided thereon anadhesive layer 40 in any of the forms described elsewhere herein. FIG.17 is a schematic diagram showing the nasal cannula 78 in use whereinthe adhesive layer 40 provided on the inner surface 70 of the attachmentpanel 64 is removeably adhered to the left alar sidewall 74B of the nose75 of the user.

FIG. 18 is an isometric view of a patient interface device in the formof a nasal cannula 82 according to still a further embodiment of theinvention. The nasal cannula 82 includes fluid delivery tubes 56A and56B connected to opposite ends of a fluid delivery barrel 84. The fluiddelivery tubes 56A and 56B are in fluid communication with a source offluid (not shown), such as an oxygen source, and deliver the fluid,e.g., oxygen, from the source to the fluid delivery barrel 84. First andsecond nasal inserts 60A and 60B are in fluid communication with thefluid delivery barrel 84 and are structured to be received in the naresof a user. The fluid delivery barrel 84 includes a first outer topsurface 86A adjacent to the outside of the nasal insert 60A, a secondouter top surface 86B adjacent to the outside of the nasal insert 60B,and an inner top surface 88 between the nasal inserts 60A and 60B. Thefirst outer top surface 86A, the second outer top surface 86B, and theinner top surface 88 each have provided thereon an adhesive layer 40 inany of the forms described elsewhere herein. When in use, the first andsecond nasal inserts 60A and 60B are inserted within the nares 72A and72B of the user. In that position, the first outer top surface 86A, thesecond outer top surface 86B, and the inner top surface 88 are each ableto be removeably adhered to the underside of the nose 75 of the user.Specifically, the adhesive layers 40 provided on the first outer topsurface 86A and the second outer top surface 86B are able to beremoveably adhered to the exterior of the user's nares, and the adhesivelayer 40 provided on the inner top surface 88 is able to be removeablyadhered to the user's septum. As a result, the nasal cannula 82 issecurely held in place while in use.

FIG. 19 is an isometric view of a patient interface device in the formof a nasal cannula 90 according to yet a further embodiment of theinvention. The nasal cannula 90 includes fluid delivery tubes 56A and56B connected to opposite ends of a fluid delivery barrel 58. The fluiddelivery tubes 56A and 56B are in fluid communication with a source offluid (not shown), such as an oxygen source, and deliver the fluid,e.g., oxygen, from the source to the fluid delivery barrel 58. First andsecond nasal inserts 60A and 60B are in fluid communication with thefluid delivery barrel 58. The first and second nasal inserts 60A and 60Bare structured to be received in the nares of a user so that the fluid,e.g., oxygen, can be delivered from the fluid delivery barrel 58 to thenasal passageway of the user. The nasal cannula 90 further includes afirst attachment panel 92A and a second attachment panel 92B that areeach connected to the fluid delivery barrel 58. Each attachment panel92A, 92B includes an inner surface 94 which has provided thereon anadhesive layer 40 in any of the forms described elsewhere herein. Whenin use, the first and second nasal inserts 60A and 60B are insertedwithin the nares 72A and 72B of the user. In that position, theattachment panels 92A and 92B are able to be removeably adhered to theexterior of the user's nares by the adhesive layers 40 provided thereon.As a result, the nasal cannula 90 is securely held in place while inuse.

FIG. 20 is a schematic diagram showing of a patient interface device inthe form of a nasal cannula 96 according to yet a further embodiment ofthe invention. The nasal cannula 96 includes fluid delivery tubes 56Aand 56B connected to opposite ends of a fluid delivery barrel 58. Thefluid delivery tubes 56A and 56B are in fluid communication with asource of fluid (not shown), such as an oxygen source, and deliver thefluid, e.g., oxygen, from the source to the fluid delivery barrel 58.First and second nasal inserts 60A and 60B are in fluid communicationwith the fluid delivery barrel 58. The first and second nasal inserts60A and 60B are structured to be received in the nares 72A and 72B of auser so that the fluid, e.g., oxygen, can be delivered from the fluiddelivery barrel 58 to the nasal passageway of the user. The nasalcannula 96 further includes a first attachment panel 98A moveablythreaded onto the fluid delivery tube 56A and a second attachment panel98B moveably threaded onto the fluid delivery tube 56. In particular,the fluid delivery tube 56A, 56B is passed through apertures 100provided in the respective attachment panel 98A, 98B so that theattachment panel 98A, 98B is able to slide along the fluid delivery tube56A, 56B. As will become apparent below, this allows each attachmentpanel 98A, 98B to be selectively (and independently) positioned by theuser. Each attachment pad 98A, 98B includes an inner surface which hasprovided thereon an adhesive layer 40 in any of the forms describedelsewhere herein. When in use, the first and second nasal inserts 60Aand 60B are inserted within the nares 72A and 72B of the user. In thatposition, the attachment panels 98A and 98B are able to be removeablyadhered to the exterior of the user's face (e.g., between the nose andmouth) at positions selected by the user by the adhesive layers 40provided thereon. As a result, the nasal cannula 96 is securely held inplace while in use.

As will be appreciated, each of the components of the nasal cannulas 76,76′, 78, 82, 90 and 96 may be molded out of a suitable polymericmaterial such as, without limitation, silicone rubber or urethane.

While preferred embodiments of the invention have been described andillustrated above, it should be understood that these are exemplary ofthe invention and are not to be considered as limiting. Additions,deletions, substitutions, and other modifications can be made withoutdeparting from the spirit or scope of the present invention.Accordingly, the invention is not to be considered as limited by theforegoing description but is only limited by the scope of the appendedclaims.

What is claimed is:
 1. A nasal cannula, comprising; one or more nasalinserts for delivering a fluid to a nasal passageway of a user; at leastone attachment panel; and an adhesive layer provided on the at least oneattachment panel and being structured to temporarily bond to the skin ofsuch a user, the adhesive layer comprising a polymer gel.
 2. The nasalcannula according to claim 1, wherein the adhesive layer furtherincludes a coating layer formed by co-curing the polymer gel with atleast one layer of a primer material.
 3. The nasal cannula according toclaim 1, wherein the polymer gel is selected from the group consistingof a silicone gel and a polyurethane gel.
 4. The nasal cannula accordingto claim 1, wherein the polymer gel has a residual extraction force ofbetween about 50 grams and about 200 grams.
 5. The nasal cannulaaccording to claim 3, wherein the polymer gel has a residual extractionforce of about 160 grams.
 6. The nasal cannula according to claim 1,wherein the nasal cannula includes a fluid delivery tube in fluidcommunication with the one or more nasal inserts, and wherein the fluiddelivery tube is inserted through one or more apertures provided in theat least one attachment panel, whereby the at least one attachment panelis free to move relative to the fluid delivery tube prior to beingtemporarily bonded to the skin of such a user.
 7. The nasal cannulaaccording to claim 1, wherein the nasal cannula includes a first fluiddelivery tube and a second fluid delivery tube in fluid communicationwith the one or more nasal inserts, wherein the at least one attachmentpanel comprises a first attachment panel and a second attachment panelconnected to one another by a connecting strip, and wherein the firstfluid delivery tube is inserted through an aperture provided in thefirst attachment panel and the second fluid delivery tube is insertedthrough an aperture provided in the second attachment panel, whereby thefirst attachment panel is free to move relative to the first fluiddelivery tube and the second attachment panel is free to move relativeto the second fluid delivery tube.
 8. A nasal cannula, comprising; oneor more nasal inserts for delivering a fluid to a nasal passageway of auser; a fluid delivery barrel in fluid communication with the one ormore nasal inserts; and an adhesive layer provided on one or more outersurfaces of the fluid delivery barrel and being structured totemporarily bond to the skin of such a user, the adhesive layercomprising a polymer gel.
 9. The nasal cannula according to claim 8,wherein the adhesive layer further includes a coating layer formed byco-curing the polymer gel with at least one layer of a primer material.10. The nasal cannula according to claim 8, wherein the polymer gel isselected from the group consisting of a silicone gel and a polyurethanegel.
 11. The nasal cannula according to claim 8, wherein the polymer gelhas a residual extraction force of between about 50 grams and about 200grams.
 12. The nasal cannula according to claim 10, wherein the polymergel has a residual extraction force of about 160 grams.